FDA Says 12-15 Year Olds Can Get Pfizer-BioNTech COVID-19 Vaccine

The US FDA has authorized the Pfizer-BioNTech COVID-19 vaccine for adolescents, extending immunizations to those 12 through 15 years of age. The vaccine had already been authorized for use on those 16 years old or above, and this is the first time a vaccine deployed in the US had sought a revision to the FDA's Emergency Use Authorization (EUA) to cover younger people.

The impact of COVID-19 on children and adolescents has been a controversial topic since the beginning of the pandemic. Despite suggestions from some quarters that young people couldn't catch coronavirus, the data has shown that not to be the case. However, "children and adolescents generally have a milder COVID-19 disease course as compared to adults," the FDA says.

Between March 1, 2020 through April 30, 2021, the FDA said today, around 1.5 million COVID-19 cases in young people aged 11 to 17 have been reported to the CDC. Even if the experience of COVID-19 infection is less intense, then, there's still the potential for spreading it to others. That's been a not-insignificant hurdle to reopening schools, for example.

Now, with the submission of new data covering the administration of Pfizer-BioNTech's drug to a younger cohort, the FDA is expanding the pharma companies' existing EUA.

"Today's action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic," Acting FDA Commissioner Janet Woodcock, M.D. said today in a statement. "Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations."

The vaccine will be administered in the same way that it has currently been used, with two doses separated by three weeks. As with adults, adolescents will be considered "fully vaccinated" two weeks after the second, final dose.

To prove both the safety and efficacy, the trial included 2,260 participants ages 12 through 15 years old in the US. Roughly half were given the Pfizer-BioNTech vaccine, and the remaining half a saline placebo. Those given the vaccine were then followed for safety for at least two months after their second dose.

As with adults, the most commonly-reported side effects for adolescents were injection-site pain, tiredness and headaches, chills, muscles pain, fever, and joint pain. More reported side effects after the second dose than the first, it's pointed out. "It is important to note that as a general matter, while some individuals experience side effects following any vaccination, not every individual's experience will be the same and some people may not experience side effects," the FDA points out. Importantly, you don't need to feel side effects in order for the vaccine to be effective.

Tests of those vaccinated suggested it was 100-percent effective in adolescents at preventing COVID-19. Still to be confirmed, meanwhile, is how long the vaccine will provide protection. Similarly, it's unclear at this relatively early stage whether the vaccine can prevent transmission between individuals.

Before vaccinations can begin among 12-15 year olds, the US CDC will have to meet to decide whether to go ahead based on the FDA's authorization. The CDC is expected to meet on Wednesday to decide that, with vaccinations under the newly-extended EUA not likely to begin until after that point.